Registration Dossier

Administrative data

Description of key information

In a limited early acute oral toxicity study female rats were dosed with 5000 mg/kg bw C.I. Direct Blue 264. 2/10 animals died during the 14 days observation period, consequently the oral LD50 is above 5000 mg/kg bw.
In an acute dermal toxicity study conducted according to OECD TG 402 C.I. Direct Blue 264 is regarded as non-toxic after dermal application. The limit dose is 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Early study conducted according to scientifically accepted method
Qualifier:
no guideline followed
Principles of method if other than guideline:
10 female Wistar rats were dosed by gavage with a single dose of C.I. Direct Blue 264. Animals were observed for 14 days and number of death and alive animals were recorded.
GLP compliance:
no
Test type:
other: Limit test
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Route of administration:
oral: gavage
Vehicle:
peanut oil
Doses:
5
No. of animals per sex per dose:
10
Control animals:
no
Sex:
female
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.

Single dose of 5000 mg/kg bw was used. 2/10 animals died during the 14 day observation period.

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
In a limited early acute oral toxicity study in female rats. 2/10 animals died during the 14 days observation period, consequently the oral LD50 is above 5000 mg/kg bw.
Executive summary:

In a limited early acute oral toxicity study in female rats. 2/10 animals died during the 14 days observation period, consequently the oral LD50 is above 5000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 6 females
Control animals:
not required
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
2 000 mg/kg bw
Based on:
test mat.

Groups of 5 male and 5 female Wistar rats received a single dermal dose of 2000 mg/kg bw of C.I. Direct Blue 264 applied semiocclusively for 24 hours.

A dose of 2000 mg/kg bw was tolerated by male and female rats without mortalities, toxicologically relevant clinical signs, toxicological effects on weight development and gross pathological findings.

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
In an acute dermal toxicity study conducted according to OECD TG 402 C.I. Direct Blue 264 is regarded as non-toxic after dermal application.
Executive summary:

Groups of 5 male and 5 female Wistar rats received a single dermal dose of 2000 mg/kg bw of C.I. Direct Blue 264 applied semiocclusively for 24 hours.

A dose of 2000 mg/kg bw was tolerated by male and female rats without mortalities, toxicologically relevant clinical signs, toxicological effects on weight development and gross pathological findings.

 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw

Additional information

In a limited early acute oral toxicity study female rats were dosed with 5000 mg/kg bw C.I. Direct Blue 264. 2/10 animals died during the 14 days observation period, consequently the oral LD50 is above 5000 mg/kg bw.

In an acute dermal toxicity study conducted according to OECD TG 402 C.I. Direct Blue 264 is regarded as non-toxic after dermal application. The limit dose is 2000 mg/kg bw.

 

Justification for classification or non-classification

C.I. Direct Blue 264 is of low toxicity and no classification according to DSD or GHS is required.